Recruiting

Cefadroxil

Sponsor:

Texas Tech University Health Sciences Center, El Paso

Code:

NCT07561541

Conditions

Fracture Lower Leg

Diabetes

Fracture Fixation, Internal

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cefadroxil 500 mg Capsules

Clindamycin

Bactrim DS

Study Details

Brief summary:

The goal of this clinical trial is to learn if taking an antibiotic pill for 7 days after surgery reduces the risk of wound infection in adults with poorly controlled diabetes who have surgery to fix a broken bone in the leg, ankle, or foot. It will also learn about the safety of the extended antibiotic course. The main questions it aims to answer are:

Does a 7-day antibiotic course after surgery lower the rate of wound infection within 90 days? What medical problems do participants have when taking the extended antibiotic course?

Researchers will compare a 7-day course of an oral antibiotic (cefadroxil) to standard care (no additional antibiotics after surgery) to see if the extended course reduces infections.

Participants will:

Take an antibiotic pill or receive standard care for 7 days after surgery Receive a phone call from the study team about 1 week after surgery Visit the clinic at 3 weeks, 6 weeks, and 3 months after surgery for checkups

Conditions

Fracture Lower Leg

Diabetes

Fracture Fixation, Internal

Study ID

NCT07561541

Start date

Apr 1, 2026

Status verified date

May, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Low extremity fracture requiring surgical treatment
  • Uncontrolled diabetes (Hemoglobin A1c > 7.0 or random glucose > 200 mg/dL)
  • Age 18 years or older
  • Able to provide informed consent
  • English or Spanish speaker

Exclusion Criteria:

  • Known allergy to prescribed antibiotic and pre-determined alternatives
  • Open fractures
  • Current infection requiring antibiotic treatment
  • Immunocompromised status (chemotherapy, immunosuppressant medications)
  • End-stage renal disease that medication dosing cannot be adjusted for
  • Pregnant or breast-feeding
  • Unable to comply with follow-up

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: No extended oral antibiotic prophylaxis

No additional extended oral antibiotic prophylaxis beyond institutional perioperative protocols.

experimental: Extended oral antibiotic prophylaxis

Extended oral antibiotic therapy in addition to institutional protocols for perioperative antibiotic therapy

Interventions

Cefadroxil 500 mg Capsules

Cefadroxil 500 mg, twice a day for 7 days

Clindamycin

Clindamycin 300 mg, three times a day for 7 days

Bactrim DS

Bactrim DS, twice a day for 7 days

Primary outcome measure

  • Surgical site infection [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Taylor M Yong, MD, MS

915-215-5480tayong@ttuhsc.edu

Locations

University of Southern California

Recruiting

Los Angeles, California, United States, 90033

Contacts

Sarah Blumenthal, MD

800-872-2273Sarah.Blumenthal@med.usc.edu

University Medical Center of El Paso

Recruiting

El Paso, Texas, United States, 79905

Contacts

Taylor Yong

8322027406tayong@ttuhsc.edu

Texas Tech Health El Paso

Recruiting

El Paso, Texas, United States, 79912

Contacts

Taylor M Yong, MD, MS

915-215-5480tayong@ttuhsc.edu

More Information

Sponsor

Texas Tech University Health Sciences Center, El Paso

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

  • Diabetes
  • Lower extremity fracture
  • Extended oral antibiotic prophylaxis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas Tech University Health Sciences Center, El Paso on 2026-05-08.